QOL Assessment Research Articles

A real-world study on the clinicopathological profile, treatment outcomes and health-related quality of life, anxiety and depression among patients with desmoid tumor at two tertiary care centers in India

BackgroundThe medical management of DT comprises tyrosine kinase inhibitors (TKIs), hormonal agents, anti-inflammatory drugs with the recently approved gamma secretase inhibitor nirogacestat being the current standard of care. Real-world data on evolving treatment landscapes of DT remains scarce.MethodsThis is a retrospective study of patients with DT registered between 1995 and 2020 at All India Institute of Medical Sciences, New Delhi and Tata Medical Center, Kolkata. Baseline characteristics were analyzed in form of median values and interquartile range. Categorical and continuous variables were compared by chi square and independent samples T- tests respectively. Anxiety, depression and QoL were prospectively measured among 30 patients using Hospital Anxiety and Depression (HADS) and Functional Assessment of Cancer Therapy-General (FACT-G) scales respectively between 2022 to 2023.Results200 patients were included with a male-predominant (n=111, 55.5%) population and median age 26.5 (2.5-75) years. Extremity (n=100, 50%) and abdomen (n=65, 32.5%) were commonest primary sites and median of 2 (1–4) lines of treatment were received. First-line included surgery (n=116, 58%), systemic therapy (n=67, 33.5%), radiotherapy (10, n=5%) and active surveillance (n=7, 3.5%). First-line systemic agents included tamoxifen (n=55, 27.5%), imatinib (n=7, 3.5%), sorafenib (n=1, 0.5%) and chemotherapy (n=4, 2%). 2019 onward, 3% and 63% underwent active surveillance and surgery respectively. Best radiological response obtained with tamoxifen was stable disease (SD) (n=76, 59%) and partial response (PR) (n=31, 24.2%). Best radiological response obtained with sorafenib was PR (n=17, 60.7%) and SD (n=9, 32.1%). Thirty patients underwent HADS and FACT-G scale assessment. Mean HADS-Anxiety subscale score was 3.6 (+/-3.9 SD) and HADS-Depression sub-scale score was 2.6 (+/-3.5 SD) with clinically significant anxiety and depression in 2 (6.7%) patients each. The overall mean FACT-G score was 87.5 (+/-12.6 SD) and lower mean physical well-being (p=0.006) and emotional well-being (0.017) scores were significantly associated with higher HADS-anxiety (>/=8) scores.ConclusionsAssessment of anxiety, depression and QoL are paramount to gauge the psychological impact of DT. This study gives an overview of clinical and management profile of patients with DT in India, with limitations of selection bias, heterogeneous population and small sample size for QoL assessment.

Comparing Ribociclib versus Palbociclib as a Second Line Treatment in Combination with Fulvestrant in Metastatic Breast Cancer: A Randomized Clinical Trial.

Assessment of CBR, PFS, QOL and toxicity profile of palbociclib and ribociclib. This is an interventional concurrent randomised phase III open label clinical trial. It took place at the Oncology Centre Mansoura University, Egypt from July 2022 till December 2023. Patients with pathologically proved ER+ HER2- metastatic breast cancer who either progressed on adjuvant hormonal or progressed on 1st line hormonal for metastatic disease. Patients in arm A received palbociclib 125 mg/day orally for 3 weeks and 1 week rest, plus fulvestrant. Patients in Arm B received ribociclib at a dose of 600 mg, administered orally once daily for 3 weeks and 1 week rest, plus fulvestrant. Pre- and peri-menopausal women received the LHRH agonist goserelin. Patients who lost their endorsement and were considered to be lost to follow up. Quality of life was analysed using the (EORTC) quality-of-life questionnaire (QLQ)-C30 V3.0. Patients were asked to complete the questionnaires at screening; at the 2nd and 6th month. Toxicity was assessed and graded using (CTCAE) v5.0. Patients were evaluated clinically for response and toxicity monthly and radiologically by CT and tumor markers/ 3 months. Treatment continued until objective Progressive Disease (PD), symptomatic deterioration, unacceptable toxicity or death. Both arms had similar baseline characteristics. There was no statistically significant difference regarding the CBR (58.6% for both arms at 6 months and 13.8% in the palbociclib VS 17.2% in the ribociclib arm at 12 months). The median PFS to the whole population was 13 months. COX multivariate analysis revealed that postmenopausal had 2.85 more likely to survive than premenopausal patients. Patients with ECOG performance status 2 and 3 are 0.13 and 0.39 less likely to survive compared to patients with PS 1. Dose reduction increased the likelihood of survival 3.36 compared with no dose reduction. The median PFS was 13.67 months in the palbociclib arm and 12.69 months in the ribociclib arm with no statistically significant difference. During follow up, there was statistically significant improvement in insomnia in both arms and constipation in the palbociclib arm alone. Comparing the two arms, no statistically significant deterioration in the QOL domains except in fatigue and financial difficulties, with more deterioration in the palbociclib arm. Regarding common toxicities there was no statistically significant difference between the 2 arms. Both Ribociclib and palbociclib have similar CBR, PFS and toxicity profile.

“How long is life worth living for the horse?” A focus group study on how Austrian equine stakeholders assess quality of life for chronically ill or old horses

BackgroundQuality of life (QoL) provides a comprehensive concept underpinning veterinary decision-making that encompasses factors beyond physical health. It becomes particularly pertinent when seeking responsible choices for chronically ill or old horses that emphasise their well-being and a good QoL over the extension of life. How different stakeholders use the concept of QoL is highly relevant when considering the complexity of these decisions in real-life situations.MethodsSeven focus group discussions (N = 39) were conducted to gain insights into how stakeholders assess and use equine QoL in veterinary care decisions for chronically ill and/or old horses. The discussions included horse owners (n = 17), equine veterinarians (n = 7), veterinary officers (n = 6), farriers (n = 4), and horse caregivers (n = 5). The combination of deductive and inductive qualitative content analysis of the group discussions focused on identifying both similarities and differences in the views of these groups regarding QoL for old and/or chronically ill horses.ResultsFindings show agreement about two issues: the importance of the individuality of the horse for assessing QoL and the relevance of QoL in making decisions about veterinary interventions. We identified differences between the groups with respect to three issues: the time required to assess QoL, stakeholders’ contributions to QoL assessments, and challenges resulting from those contributions. While owners and caregivers of horses emphasised their knowledge of a horse and the relevance of the time they spend with their horse, the veterinarians in the study focused on the differences between their own QoL assessments and those of horse owners. In response to challenges regarding QoL assessments and decision-making, stakeholders described different strategies such as drawing comparisons to human experiences.ConclusionsDifferences between stakeholders regarding equine QoL assessments contribute to challenges when making decisions about the care of chronically ill or old horses. The results of this study suggest that individual and collaborative reflection about a horse’s QoL should be encouraged, for example by developing practicable QoL assessment tools that support relevant stakeholders in this process.

Prospective comparative study of quality of life in patients with bladder cancer undergoing cystectomy with ileal conduit or bladder preservation

ObjectiveTo compare health-related quality of life (HRQOL) in patients undergoing radical cystectomy with ileal conduit (RC) or bladder preservation (BP) with (chemo)radiotherapy for bladder cancer.Methods and analysisPatients with bladder cancer,...

Cardiac Health Assessment Using a Wearable Device Before and After Transcatheter Aortic Valve Implantation: Prospective Study.

Due to aging of the population, the prevalence of aortic valve stenosis will increase drastically in upcoming years. Consequently, transcatheter aortic valve implantation (TAVI) procedures will also expand worldwide. Optimal selection of patients who benefit with improved symptoms and prognoses is key, since TAVI is not without its risks. Currently, we are not able to adequately predict functional outcomes after TAVI. Quality of life measurement tools and traditional functional assessment tests do not always agree and can depend on factors unrelated to heart disease. Activity tracking using wearable devices might provide a more comprehensive assessment. This study aimed to identify objective parameters (eg, change in heart rate) associated with improvement after TAVI for severe aortic stenosis from a wearable device. In total, 100 patients undergoing routine TAVI wore a Philips Health Watch device for 1 week before and after the procedure. Watch data were analyzed offline-before TAVI for 97 patients and after TAVI for 75 patients. Parameters such as the total number of steps and activity time did not change, in contrast to improvements in the 6-minute walking test (6MWT) and physical limitation domain of the transformed WHOQOL-BREF questionnaire. These findings, in an older TAVI population, show that watch-based parameters, such as the number of steps, do not change after TAVI, unlike traditional 6MWT and QoL assessments. Basic wearable device parameters might be less appropriate for measuring treatment effects from TAVI.

A phase 1, open-label, dose escalation study on the safety and tolerability of ANK-101 in advanced solid tumors.

TPS2689 Background: IL-12 is a cytokine that can stimulate both innate and adaptive tumor immunity. Clinical trials of intravenous IL-12 demonstrated anti-tumor activity limited by significant systemic toxicity, including patient deaths. ANK-101 is an anchored immunotherapy that links IL-12 to aluminum hydroxide through an alum-binding protein (ABP). The ANK-101 complex anchors IL-12 in the tumor microenvironment (TME), resulting in prolonged local retention and low levels of systemic absorption. Preclinical studies in murine tumor models showed that ANK-101 is retained at the injection site for up to 28 days, recruits and activates T and NK cells, promotes M1 myeloid cell differentiation, induces regression of both injected and un-injected tumors, and induces immunologic memory. Methods: This is a first-in-human, open-label dose escalation study of ANK-101 in advanced solid tumors with a planned sample size of 12-36 participants. The first three dose escalation cohorts include a single participant, and then study enrollment follows a standard 3+3 dose escalation design. If no dose limiting toxicity (DLT) is observed, the dose level will be escalated until ≥1/3 or ≥2/6 patients experience a DLT. An additional ten patients will be enrolled at the recommended dose for expansion (RDE). Participants will be treated with intratumoral ANK-101 every 3 weeks for 4 cycles. Imaging or clinical assessments will be performed at week 12. If there is no significant clinical deterioration or unacceptable toxicity at this visit, participants may receive four more cycles. Eligible patients must have an advanced solid malignancy refractory to standard treatment and be accessible for injection and biopsy, measurable disease by RECIST v1.1, and ECOG PS of 0-1. Key exclusion criteria include tumors close to vital structures, uncontrolled bleeding disorders, and active autoimmune disease. Primary objectives of the study are to determine the safety and tolerability of ANK-101 and identify the RDE. Secondary objectives include pharmacokinetics (PK) and immunogenicity (ADA) of ANK-101 and clinical activity as measured by ORR, DCR, DOR and PFS by RECIST v1.1. Exploratory objectives include assessment of QOL using FACT-G and profiling immune-based pharmacodynamic (PD) changes. PD assessments will include serum cytokines and circulating immune cells, and local levels of PD-L1, CD8+ T cells, and CD68+ macrophages, and changes in gene expression within the TME. This clinical trial is in progress. Clinical trial information: NCT06171750 .

A Descriptive Study to Assess the Quality of Life of Patients Undergoing Hemodialysis in Sharda Hospital, Greater Noida

Background of the Study: Assessment of QoL of patients with ESRD and CKD has been serving a notable purpose in evaluating the influence of the disease on patients. ESRD is a chronic disease condition that significantly degrades a patient’s health-related QoL, mostly because it places barrier on a patient’s health and wellness inclusive of physical health, psychological health, and social health.  Aim of the Study: The main purpose of the research study is to assess the QoL of patients undergoing haemodialysis and to find out the relationship between QoL with selected socio- demographic variables. This study also examines the effects of haemodialysis on patient’s ability to perform activities of daily living (ADLs).  Methods: It is a descriptive study carried out among 50 patients of Sharda Hospital, Greater Noida. Non- probability convenience sampling technique was used. The data was collected through a WHOQOL-BREF assessment scale and a validated, self-designed socio- demographic tool.  Results: The result shows that there is a notable association (p<0.05) between gender and QOL (i.e. males are having better quality of life than females.). Majority 48.0% of the patients describe their overall QoL as fair 38.0% describe it as bad and about 14.0% describe it as good.  Conclusion: The quality of life assessment revealed that approximately half of the patients who participated in the research have rated their quality of life as fair, while a significant portion considered it to be bad and a smaller percentage reported a good quality of life.  Activities of Daily Living: Collectively describes fundamental skills required to independently care for oneself, such as bathing, eating etc.

P.039 Informing treatment advancement and innovation in a tertiary care neurocritical care (NCC)) program

Background: Children with neurological injuries/insults carry the highest risk of death and disability in Pediatric and Neonatal ICUs. These patients comprise 25-30% of admissions and have a myriad of diagnoses. Longitudinal outcome data is required to inform treatment effects and innovation strategies. NCC at the Alberta Children’s Hospital (ACH) participates in acute, subacute, and long-term/outpatient management with an aim to use comprehensive clinical data to improve outcomes. Methods: A prospective, longitudinal, population-based observational cohort study of NCC patients from local NICUs, PICU, and a NCC follow-up program, with comprehensive data from clinical records, development scores and QoL assessments. Results: Since 2019, 929 patients have been enrolled including: 407 neonates, 167 infants, 106 preschool-age and 100 school-age children, and 152 adolescents. The most common reasons for NCC consult were paroxysmal events (36%), encephalopathy (27%) and neonatal HIE (20%). Conclusions: Our database encapsulates the diverse nature of NCC patients and has enabled cohort-specific studies (e.g., neonatal HIE and ECLS outcomes). Program evolution will further facilitate higher powered research studies through large enrollment, comprehensive data capture (with a provincial EHR), and longitudinal outcomes. Engagement with staff and families will also inform treatment and afford evidence-based counseling to families.

Item analysis on the quality of life scale for anxiety disorders QLICD-AD(V2.0) based on classical test theory and item response theory

BackgroundAnxiety disorders can cause serious physical and psychological damage, so many anxiety scales have been developed internationally to measure anxiety disorders, but due to the cultural differences and cultural dependence of quality of life between Chinese and Western cultures, it is difficult to reflect the main characteristics of Chinese patients. Therefore, we developed a scale suitable for Chinese patients with anxiety disorders: the Anxiety Disorders Scale of the Quality of Life Instruments for Chronic Diseases (QLICD-AD), hoping to achieve satisfactory QOL assessments for anxiety disorders.ObjectivesItems from the Anxiety Disorders Scale of the Quality of Life in Chronic Disease Instrument QLICD-AD system were analyzed using CTT and IRT to lay the groundwork for further refinement of the scale to accurately measure anxiety disorders.Methods120 patients with anxiety disorder were assessed using the QLICD-AD (V2.0). Descriptive statistics, variability method, correlation coefficient method, factor analysis and Cronbach’s coefficient of CTT, and graded response model (GRM) of item response theory were used to analyze the items of the scale.ResultCTT analysis showed that the standard deviation of each item was between 0.928 and 1.466; Pearson correlation coefficients of item-to-domain were generally greater than 0.5 and also greater than that of item-to-other domain; the Cronbach ‘s of the total scale was 0.931, α of each domain was between 0.706 and 0.865. IRT analysis showed that the discrimination was between 1.14 and 1.44. The difficulty parameter of all items increased with the increase of grade. But some items (GPH6,GPH8,GPS3,GSO2-GSO4,AD2,AD5) difficulty parameters were less than 4 or greater than 4. The average of information amount was between 0.022 and 0.910.ConclusionBased on CTT and IRT analysis, most items of the QLICD-AD (V2.0) scale have good performance and good differentiation, but a few items still need further revision. Suggests that the QLICD-AD (V2.0) appears to be a valid measure of anxiety disorders. It may effectively improve the diagnosticity of anxiety disorders, but due to the limitations of the current sample, further validation is needed in a broader population extrapolation trial.

Long-term outcomes in non-CAH 46,XX DSD.

Differences/disorders of sex development (DSD) comprise a large group of rare congenital conditions. 46,XX DSD, excluding congenital adrenal hyperplasia (CAH), represent only a small number of these diseases. Due to the rarity of non-CAH 46,XX DSD, data on this sex chromosomal aberration were confined to case reports or case series with small numbers of patients. As the literature is still relatively sparse, medical data on the long-term effects of these pathologies remain scarce. In this review, we aim to provide an overview of current data on the long-term follow-up of patients with non-CAH 46,XX DSD, by covering the following topics: quality of life, gender identity, fertility and sexuality, global health, bone and cardiometabolic effects, cancer risk, and mortality. As non-CAH 46,XX DSD is a very rare condition, we have no accurate data on adult QoL assessment for these patients. Various factors may contribute to a legitimate questioning about their gender identity, which may differ from their sex assigned at birth. A significant proportion of gender dysphoria has been reported in various series of 46,XX DSD patients. However, it is difficult to give an accurate prevalence of gender dysphoria and gender reassignment in non-CAH 46,XX DSD because of the rarity of the data. Whatever the aetiology of non-CAH 46,XX DSD, fertility seems to be impaired. On the other hand, sexuality appears preserved in 46,XX men, whereas it is impaired in women with MRKH syndrome before treatment. Although there is still a paucity of data on general health, bone and cardiometabolic effects, and mortality, it would appear that the 46,XX DSD condition is less severely affected than other DSD conditions. Further structured and continued multi-center follow-up is needed to provide more information on the long-term outcome of this very rare non-CAH 46,XX DSD condition.

Effect of myofascial release and muscle energy technique on patients with chronic neck pain: a scoping review.

To identify the effects of muscle energy techniques and myofascial release in patients with chronic neck pain. To conduct a literature search and identification; PRISMA-ScR guidelines were followed. Relevant articles were searched for from the following medical and health sciences electronic databases: PubMed, EBSCOhost, CENTRAL of the Cochrane Library, and the Physiotherapy Evidence-Based Database (PEDro). Patients with chronic neck pain were eligible for the scoping review. Seven articles were included in this review. This scoping review found that there is heterogeneity in the prescription of MFR and MET and a greater tendency to check three major physical dimensions (pain, range of motion, and disability). Various studies have opted for distinct intervention regimens, resulting in disparities in the frequency of weekly interventions, which can range from biweekly to five times a week. These inconsistencies may lead to perplexity among practitioners, as each intervention modality demonstrates favorable outcomes for individuals with persistent cervical discomfort. Moreover, a significant proportion of research projects have employed the numeric pain rating scale (NPRS) and visual analog scale (VAS) for data quantification. According to results, majority of the studies were focused on pain and missing components of range of motion and quality of life. Work-related factors can act as risk factors for chronic neck pain. Future investigations should adopt a comprehensive methodology and incorporate QoL assessments of quality of life.

Factors Associated with Health-Related Quality of Life Among Breast Cancer Survivors in Saudi Arabia: Cross-Sectional Study.

Assessment of health-related quality of life (HRQOL) is a major concern among breast cancer survivors. Little is known about HRQO and its determinants in Saudi women with breast cancer (BC). This study aimed to describe the HRQOL of Saudi women with breast cancer and the association between HRQO and sociodemographic and clinical variables. This cross-sectional study involved 147 BC participants who completed the 36-item Short Form Health Survey (SF-36). Multivariable linear logistic regression analysis was conducted to determine factors associated with HRQOL. For the physical component scale, general health scored the highest (55.41±17.99) while, role physical function scored the lowest (48.61±22.51). The mean scores in the mental component were higher for social function (56.91±20.84), while the lowest score was observed for energy and vitality (49.62±20.84). Significant differences were observed in many SF-36 domains across the sociodemographic and clinical variables. Older age, having had a mastectomy as well as comorbid conditions, and receiving chemotherapy and hormonal therapy were associated with decreased HRQOL. However, being physically active, employed, and having more education were associated with higher HRQOL. HRQOL is generally poor among breast cancer survivors in Saudi Arabia, depending on a variety of factors. These findings highlight the need for routine QOL assessment. Furthermore, recognizing these predictors may play a key role in maximizing HRQOL for breast cancer participants.

A Cross-Sectional, Multicentric, Disease-Specific, Health-Related Quality of Life Study in Greek Transfusion Dependent Thalassemia Patients.

The assessment of health-related quality of life (HRQoL) in thalassemia offers a holistic approach to the disease and facilitates better communication between physicians and patients. This study aimed to evaluate the HRQoL of transfusion-dependent thalassemia (TDT) patients in Greece. This was a multicentric, cross-sectional study conducted in 2017 involving 283 adult TDT patients. All participants completed a set of two QoL questionnaires, the generic SF-36v2 and the disease-specific TranQol. Demographic and clinical characteristics were used to predefine patient subgroups. Significant factors identified in the univariate analysis were entered into a multivariate analysis to assess their effect on HRQoL. The SF-36 scores of TDT patients were consistently lower compared to the general population in Greece. The mean summary score of TranQol was relatively high (71 ± 14%), exceeding levels observed in national surveys in other countries. Employment emerged as the most significant independent factor associated with better HRQoL, whereas age had the most significant negative effect. This study represents the first comprehensive QoL assessment of a representative sample of the TDT population in Greece. The implementation of TranQol allowed for the quantification of HRQoL in Greece, establishing a baseline for future follow-up, and identifying more vulnerable patient subgroups.

Effect of Radioiodine Treatment on Quality of Life in Patients with Subclinical Hyperthyroidism: A Prospective Controlled Study.

Study aim was to evaluate thyroid-related QoL in patients with subclinical hyperthyroidism mostly due to toxic nodular goitre undergoing RIT, compared to a control group of euthyroid subjects. Study design was monocentric, prospective, controlled. Fifty control subjects were enrolled and 51 RIT patients. Most subjects were examined at least twice at an interval of 6 months, with visits immediately before and 6 months after treatment in the RIT group. QoL was estimated with the ThyPRO questionnaire, using its composite scale as primary outcome. Treatment effect was the mean adjusted difference (MAD) between groups over time, using repeated? measures mixed? effects models. TSH concentrations were lower in the RIT group prior to treatment and recovered thereafter slightly above the level of the control group. Correspondingly, QoL improved significantly after 6 months from a worse level in the RIT group, compared to controls (MAD -10.3 [95% CI -14.9, -5.7], p<0.001). QoL improvements were strong for general items, but less pronounced for the hyperthyroid domain. Compared to controls, thyroid volume, thyroid functional capacity (SPINA-GT) and deiodinase activity (SPINA-GD) were significantly reduced in the RIT group. Patients with subclinical hyperthyroidism improve both biochemically and in their QoL after RIT, compared to controls. QoL assessment should have a wider role in clinical practice to complement biochemical tests and help with treatment decisions.

Prospective observational study on quality of life in painful neuropathic pain conditions

Background: Neuropathic pain is the most complicated, disabling condition due to varied etiologies and clinical presentations, and with substantial global problem on the individual suffering with pain as well as the society he thrives in. The consequences of long effects of pain are so huge that it has an impact on one’s social, physical, psychological, behavioral domains, etc., and mainly leads to substance abuse, mood disorders, sleep disturbances, and increased suicidal tendencies which have an enormous and detrimental effect on patient’s quality of life (QOL). Aims and Objectives: The aim of this study was to assess the effect of neuropathic pain on the QOL and to determine the extent of socioeconomic burden on subjects with neuropathic pain conditions. Materials and Methods: This prospective, observational study was done on 100 successive subjects including both the gender aged 18–65 years, diagnosed with neuropathic pain conditions, who attended pain clinic (Outpatient Department) at Kempegowda Institute of Medical Sciences, Hospital and Research Centre, Bangalore, and subjects assessed for the impact of neuropathic pain conditions on the QoL and its influence on overall health using short-form (SF) 12 QoL. Results: The assessment of health-related QoL in the study subjects, regarding age group, gender, and duration of pain, concluded that scores with physical health (PH) and mental health (MH) were low in the age group of 31–50 years (54%) in both sexes. Lower scores in PH and MH dimensions were noted more in women (31%) than men. It was also noted that the scores were low in PH and MH components with increasing duration of illness. Conclusion: The health-related QoL in subjects with NP was assessed by SF-12 QoL questionnaire that evaluated the eight domains of Health, that is, PH and MH scores that summed up to PH composite scale-12 and MH composite scale-12 scores with respect to age group, gender, duration of pain, etc. and ongoing drug therapy, the results of which were statistically significant.

Quality of life in persons with mild cognitive impairment: a systematic review and meta-analysis.

The present work aimed at exploring and comparing QOL in older adults with and without MCI through a systematic review and meta-analysis. After a detailed search of articles till May 2021 in the relevant electronic databases (PubMed Central, PubMed, Scopus, CINAHL Plus, Web of Science, ProQuest, and Cochrane) using the keywords "mild cognitive impairment", "quality of life", "old", "old aged", "aged", "older adult", "geriatrics", "healthy controls", "healthy participants", and "normal controls", we included 23 articles in the systematic review and 12 in the meta-analysis. The quality of all the included articles were assessed using the Modified Downs and Black tool. Most of the studies in the systematic review demonstrated differences in QOL scores in older adults with MCI compared to healthy older adults. However, meta-analysis findings suggest that older adults with MCI had statistically non-significant yet lower differences in QOL compared to their healthy counterparts. Future research should focus on developing QOL assessment tools specifically for older adults with MCI and follow-up studies that could provide better knowledge of their changing cognitive profile and life quality.

Reliability and validity of the Turkish version of the New Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire.

This study aims to adapt and validate the Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire (CCF-CaQL) in Turkish, addressing the significant need for reliable, language-specific QoL measures for colorectal cancer (CRC) in Turkiye. This effort fills a critical gap in CRC patient care, enhancing both patient-provider communication and disease-specific QoL assessment. The CCF-CaQL was translated into Turkish, verified for accuracy, and reviewed for clarity and relevance. Eligible patients who underwent colorectal surgery for cancer between July 2021 and July 2022 from six hospitals completed the CCF-CaQL and SF-36 questionnaires. For analysis, confirmatory factor analysis using Smart PLS 4 and descriptive statistics were employed. The questionnaire's reliability and validity were assessed using Cronbach alpha, composite reliability, and the heterotrait-monotrait (HTMT) ratio, along with multicollinearity checks and factor loadings. Nonparametric resampling was used for precise error and confidence interval calculations, and the Spearman coefficient and split-half method were applied for reliability testing. In the study involving 244 colorectal cancer patients, confirmatory factor analysis of the CCF-CaQL indicated effective item performance, with one item removed due to lower factor loading. The questionnaire exhibited high internal consistency, evidenced by a Cronbach alpha value of 0.909. Convergent validity was strong, with all average variance extracted (AVE) values exceeding 0.4. Discriminant validity was confirmed with HTMT coefficients below 0.9, and no significant multicollinearity issues were observed (VIF values < 10). Parallel testing with the SF-36 scale demonstrated moderate to very strong correlations, affirming the CCF-CaQL's comparability in measuring quality of life. The Turkish version of the CCF-CaQL was validated for assessing quality of life in colorectal cancer patients. This validation confirms its reliability and cultural appropriateness for use in Turkiye. The disease-specific nature of the CCF-CaQL makes it a useful tool in clinical and research settings, enhancing patient care by accurately monitoring treatment effects and interventions in the Turkish colorectal cancer patient population.

Effects of COVID-19 Lockdown on Heart Failure Patients: A Quasi-Experimental Study.

The COVID-19 lockdown has been associated with reduced levels of physical activity, quality of life, and sleep quality, but limited evidence exists for its impact on heart failure patients. This study examined the influence of the COVID-19 lockdown on these aspects in heart failure patients, with specific comparisons by age and sex. A quasi-experimental cross-sectional study of patients with heart failure was conducted. The assessment involved two time points: during the COVID-19 lockdown (March to June 2020) and post-lockdown (July to October 2020). A total of 107 HF patients participated, with assessments of overall PA (using the International Physical Activity Questionnaire), QoL (employing the Cantril Ladder of Life), and sleep quality (utilizing the Minimal Insomnia Symptom Scale) conducted during and after the COVID-19 lockdown. HF patients reported lower levels of total PA (p = 0.001) and walking PA (p < 0.0001) during lockdown than after lockdown, whilst no differences were observed in QoL nor sleep quality. In addition, both younger and older patients reported lower walking PA and total PA during lockdown than after lockdown, while older patients reported lower QoL during lockdown than after lockdown. Moreover, both men and women reported lower walking PA and total PA during lockdown than after lockdown, whilst women reported lower QoL. HF patients need improved PA programs during lockdowns, as these programs can elevate PA levels and enhance QoL, especially when faced with the risk of decompensation during health crises.

Effects of a high-protein, increased-fibre, dry diet supplemented with omega-3 fatty acids on quality of life in dogs undergoing chemotherapy.

Quality of life (QOL) in dogs with cancer is a key consideration in the assessment of cancer treatment options. Despite interest in dietary strategies to improve management of oncology patients, there have been very few clinical studies showing the impact of diet on adverse effects of chemotherapy in dogs. This study was a randomised, controlled, double-blinded, multicenter clinical trial to investigate a high-protein, increased-fibre diet supplemented with omega-3 fatty acids, for dogs with cancer undergoing standard-of-care chemotherapy. Client-owned dogs with newly diagnosed grade 2 or higher mast cell tumours (or non-resectable/incompletely resected tumours) or multicentric lymphoma were randomised to receive the test diet (n = 24) or control diet (n = 21) for 8 weeks. Primary outcomes were QOL assessments, faecal scores, and blood concentrations of C-reactive protein and monocyte chemoattractant protein-1. Of 12 QOL parameters, 10 significantly improved from baseline to Week 8 in the test group compared with one in the control group. However, differences between the two groups were only statistically significant for 'frequency of signs of illness' (P = .009). There were no significant differences in the incidence of any adverse events, including gastrointestinal adverse events or clinically significant differences in laboratory parameters or faecal scores between the two groups. The absence of an observed negative impact of the test diet, combined with the magnitude of QOL improvements associated with the diet, suggest that a larger trial is warranted.

Durable Symptom Improvement for Patients with Non-Transfusion Dependent Thalassemia Treated with Luspatercept: Patient-Reported Outcomes from the BEYOND Study

Background: Patients with non-transfusion dependent beta-thalassemia (NTDT) suffer from chronic anemia due to ineffective erythropoiesis. The phase 2, randomized, placebo-controlled BEYOND study demonstrated that luspatercept increased hemoglobin (Hb), reduced transfusion burden, and improved NTDT-related symptoms based on the data with 48 weeks of follow-up (Taher A, et al. Lancet Haematol. 2022;9(10):E733). Objective: The purpose of this analysis was to investigate the long-term effect of luspatercept + best supportive care (BSC) vs placebo + BSC on NTDT-related symptoms through 96 weeks using data collected in the BEYOND study. Methods: 145 patients with NTDT were randomized 2:1 to luspatercept (Q3W) + BSC or placebo + BSC. BSC included red blood cell (RBC) transfusions and iron chelation therapy as deemed necessary by investigators. Patients completed the NTDT Patient Reported Outcome (NTDT-PRO) and Patient Global Impression of Severity (PGI-S) in a daily electronic diary starting 7 days prior to the first dosing day until Week 24, and thereafter over the 7 days prior to dosing at every other dosing visit. The Patient Global Impression of Change (PGI-C) was administered at every other dosing visit, starting with the first dosing day. The NTDT-PRO consists of 6 questions measuring 2 NTDT anemia-related symptom domains: Tiredness/Weakness (T/W) and Shortness of Breath (SoB), each with a score range of 0 (no symptoms) to 10 (extreme symptoms). The PGI-S asks patients to rate the overall severity of their NTDT-related symptoms (range of 0 to 10, with a higher score indicating greater severity), whereas the PGI-C asks patients to rate the overall change in their NTDT-related symptoms since the start of the study (7-level verbal rating scale ranging from “a great deal better” to “a great deal worse”). Least squares (LS) mean changes from baseline at each visit (up to Week 96) in NTDT-PRO T/W and SoB scores, as well as the PGI-S score, were estimated using a mixed model for repeated measures (MMRM). Responses to the PGI-C were descriptively summarized by treatment group. All analyses were performed in the health-related quality of life (HRQoL)-evaluable population, defined as all randomized patients with a valid QoL assessment and at least 1 post-baseline assessment. All p-values reported from the analyses were nominal. Results: The HRQoL-evaluable population consisted of 95 of the 96 patients randomized to the luspatercept arm and all 49 patients randomized to the placebo arm. LS mean changes from baseline in both the NTDT-PRO T/W and SoB scores for the luspatercept arm consistently demonstrated greater improvement (i.e., lower scores) than the placebo arm across visits. Improvement in both T/W and SoB domains were more pronounced starting at Week 24 and sustained through Week 96, with differences in LS mean changes from baseline ranging from -0.89 to -0.21 in the T/W domain and from -0.80 to -0.45 in the SoB domain over this time period (both domains on a 0 to 10 scale). Between-treatment differences were significant (p&amp;lt;0.05) at Week 30 (between-treatment difference in LS mean change from baseline, 95% confidence interval: -0.76, -1.42 to -0.10), Week 36 (-0.89, -1.55 to -0.22), and Week 72 (-0.81, -1.54 to -0.09) in the T/W domain and at Week 30 (-0.71, -1.36 to -0.06), Week 48 (-0.77, -1.43 to -0.10), and Week 72 (-0.80, -1.51 to -0.10) in the SoB domain. LS mean changes from baseline in the severity of overall NTDT-related symptoms, assessed by the PGI-S, showed a marked improvement through Week 96 in the luspatercept arm ( Figure 1), whereas patients receiving placebo tended to worsen over time. The between-treatment difference was statistically significant (p&amp;lt;0.05) across most assessment visits from Weeks 18 to 96. For the PGI-C, most patients treated with luspatercept reported “a little better” or more on their overall NTDT-related symptoms at Weeks 72 (89%) and 96 (87%), whereas most patients receiving placebo reported no change at either Week 72 (61%) or 96 (75%) ( Figure 2). Conclusions: Analysis of the PRO data collected in BEYOND suggests that, in addition to improvements in Hb, patients with NTDT treated with luspatercept experienced durable improvement in NTDT-related symptoms, from a patient perspective, through at least 96 weeks of treatment.